An interventional study of Alcohol and Energy Drink (AmED) and Alcohol and Energy drink Placebo in Healthy and Alcohol Drinking, sponsored by Fundació Institut Germans Trias i Pujol. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-09.
Sponsored by Fundació Institut Germans Trias i Pujol · Not applicable, Interventional, and Basic science
The purpose of the study is to assess the relevance of gender in the acute effects (subjective, physiological and driving-related skills) observed after controlled administration of alcohol in a binge-drinking pattern mixed with energy drinks (AmED)
Consumption of alcohol mixed with energy drinks (AmED) has increased mainly among young people. Energy drinks (ED) are usually combined with alcohol with the intention of counteracting its effects. However, most studies have not shown a reduction in drunkenness and consumption is related with engagement of risk-taking behaviours like driving under alcohol effects. It is already known that alcohol concentrations and effects are higher in women than in men even after adjusting dose by weight.
The relevance of gender in the acute effects of alcohol associated with ED consumed in a binge-drinking pattern has been poorly studied. A randomized clinical trial will be conducted in healthy volunteers (1:1) and four treatment conditions will be administered: alcohol+ED, alcohol+placebo of ED, placebo of alcohol+ED and placebo of alcohol+placebo of ED. Subjective and physiological effects, driving related skills, and alcohol and caffeine concentrations will be measured along an 8-hours period. A pilot study has been conducted with the first 6 volunteers to select the alcohol doses. In the definitive study 70 g of alcohol in men and 55 g in women will be used.
701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.
This study's planned enrollment of 32 is below the median of 122 across 607 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →Fundació Institut Germans Trias i Pujol is the lead sponsor of 25 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The total volume of drink will be 761 ml in women and 969 ml in men. The doses will be divided into 6 fractions administered one every 15 min simulating a binge drinking pattern (80 min in total). Women: Ethanol 172 ml (55 g) + ED 589 ml Men: Ethanol 219 ml (70 g) + ED 750 ml
Dietary Supplement: Alcohol and Energy Drink (AmED)
The total volume of drink will be 761 ml in women and 969 ml in men. The doses will be divided into 6 fractions administered one every 15 min simulating a binge drinking pattern (80 min in total). Women: Ethanol 172 mL (55 g) + placebo ED (a non-caffeinated soft drink) 589 mL Men: Ethanol 219 mL(70 g) + placebo ED 750 mL (a non-caffeinated soft drink)
Dietary Supplement: Alcohol and Energy drink Placebo
The total volume of drink will be 761 ml in women and 969 ml in men. The doses will be divided into 6 fractions administered one every 15 min simulating a binge drinking pattern (80 min in total). Women: Ethanol placebo (water) 172 mL + ED 589 mL Men: Ethanol placebo (water) 219 mL + ED 750 mL
Dietary Supplement: Alcohol placebo and Energy drink
The total volume of drink will be 761 ml in women and 969 ml in men. The doses will be divided into 6 fractions administered one every 15 min simulating a binge drinking pattern (80 min in total). Women: Ethanol placebo (water) 172 mL+ placebo ED (a non-caffeinated soft drink) 589 mL Men: Ethanol placebo (water) 219 mL + placebo ED (a non-caffeinated soft drinks) 750 mL
Dietary Supplement: Alcohol placebo and energy drink placebo
Multiple oral dose of alcohol mixed with ED
Multiple oral dose of alcohol mixed with ED placebo (soft drink)
Multiple oral dose of alcohol placebo (water) mixed with ED
Multiple oral dose of alcohol placebo (water) mixed with ED placebo (soft drink)
Change in subjective effects measured with Biphasic alcohol effects scale (BAES)
Subjective effects of alcohol will be measured using Biphasic alcohol effects scale (0-70 points). Higher scores mean worse outcome. Obtained baseline and 1, 1.30, 2, 3, 4, 6 and 8-h after administration.
Time frame: From baseline to 8 hours after administration
Change in psychomotor vigilance task (PVT)
Test will be performed using a specific software. Mean latency will be measured. Obtained baseline and 1.30, 4 and 6-h after administration.
Time frame: From baseline to 6 hours after administration
Area under the concentration-time curve (AUC 0-8h) of ethanol blood concentrations
Calculation of AUC of ethanol blood concentrations. Obtained baseline and 0.30h , 1, 1.30, 2, 2.30, 3, 4, 6 and 8-h after administration.
Time frame: From baseline to 8 hours after administration
Area under the concentration-time curve (AUC 0-8h) of ethanol breath concentrations
Obtained baseline and 0.15, 0.30 , 0.45, 1, 1.15,1.30, 1.45, 2, 2.15, 2.30, 3, 4, 6 and 8-h after administration.
Time frame: From baseline to 8 hours after administration
Area under the concentration-time curve (AUC 0-8h) of caffeine blood concentrations
Calculation of AUC of caffeine concentrations obtained baseline and 0.30, 1, 1.30, 2, 2.30, 3, 4, 6 and 8-h after administration.
Time frame: From baseline to 8 hours after administration
Maximum concentration (Cmax) of ethanol in blood
Maximum concentration (Cmax) of ethanol in blood
Time frame: From baseline to 8 hours after administration
Maximum concentration (Cmax) of caffeine in plasma
Maximum concentration (Cmax) of caffeine in plasma
Time frame: From baseline to 8 hours after administration
Time to reach maximum concentration (tmax) of ethanol in blood
Time to reach maximum concentration (tmax) of ethanol in blood
Time frame: From baseline to 8 hours after administration
Time to reach maximum concentration (tmax) of ethanol in breath air
Time to reach maximum concentration (tmax) of ethanol in breath air
Time frame: From baseline to 8 hours after administration
Time to reach maximum concentration (tmax) of caffeine in plasma
Time to reach maximum concentration (tmax) of caffeine in plasma
Time frame: From baseline to 8 hours after administration
Area under the concentration-time curve (AUC 0-8h) of taurine plasma concentrations
Calculation of AUC of taurine concentrations obtained baseline and 0.30h , 1, 1.30, 2, 2.30, 3, 4, 6 and 8-h after administration
Time frame: From baseline to 8 hours after administration
Maximum concentration (Cmax) of taurine plasma concentrations
Maximum concentration (Cmax) of taurine plasma concentrations
Time frame: From baseline to 8 hours after administration
Time to reach maximum concentration (tmax) of taurine plasma concentrations
Time to reach maximum concentration (tmax) of taurine plasma concentrations
Time frame: From baseline to 8 hours after administration
Change in drunkenness feeling
Drunkenness will be measured using a visual analog scale (0-100 mm). Higher scores mean worse outcome. Obtained baseline and 0.30, 1, 1.30, 2, 2.30, 3, 4, 6 and 8-h after administration.
Time frame: From baseline to 8 hours after administration
Change in dizziness feeling
Dizziness will be measured using a visual analog scale (0-100 mm).Higher scores mean worse outcome. Obtained baseline and 0.30, 1, 1.30, 2, 2.30, 3, 4, 6 and 8-h after administration.
Time frame: From baseline to 8 hours after administration
Change in drowsiness feeling
Drowsiness will be measured using a visual analog scale (0-100 mm). Higher scores mean worse outcome. Obtained baseline and 0.30, 1, 1.30, 2, 2.30, 3, 4, 6 and 8-h after administration.
Time frame: From baseline to 8 hours after administration
Change in palpitations reported by the participant
Palpitations will be measured using a visual analog scale (0-100 mm). Higher scores mean worse outcome. Obtained baseline and 0.30, 1, 1.30, 2, 2.30, 3, 4, 6 and 8-h after administration.
Time frame: From baseline to 8 hours after administration
Change in anxiety feeling
Anxiety will be measured using a visual analog scale (0-100 mm).Higher scores mean worse outcome. Obtained baseline and 0.30, 1, 1.30, 2, 2.30, 3, 4, 6 and 8-h after administration.
Time frame: From baseline to 8 hours after administration
Change in headache
Headache will be measured using a visual analog scale (0-100 mm). Higher scores mean worse outcome. Obtained baseline and 0.30, 1, 1.30, 2, 2.30, 3, 4, 6 and 8-h after administration.
Time frame: From baseline to 8 hours after administration
Change in ability and predisposition to drive in certain situations
Will be measured using a visual analog scale (0-100 mm).Higher scores mean worse outcome. Obtained baseline and 1.30, 4, 6 and 8-h after administration.
Time frame: From baseline to 8 hours after administration
Desire to keep drinking
Will be measured using a visual analog scale (0-100 mm). Higher scores mean worse outcome. Obtained at the end of beverage administration. Only one measure at 1.30 hours.
Time frame: At 1.30 hours
Change in subjective effects measured with Addiction Research Center Inventory (ARCI)
Obtained baseline and 1, 1.45, 4, 6 and 8-h after administration.
Time frame: From baseline to 8 hours after administration
Change in blood pressure
Systolic and diastolic blood pressure (mmHg) will be measured obtained baseline and 0.30, 1, 1.30, 2, 2.30, 3, 4, 6 and 8-h after administration.
Time frame: From baseline to 8 hours after administration
Change in heart rate
Heart rate (beats/min) will be measured obtained baseline and 0.30, 1, 1.30, 2, 2.30, 3, 4, 6 and 8-h after administration.
Time frame: From baseline to 8 hours after administration
Change in oral temperature
Oral temperature (ºC) will be measured obtained baseline and 0.30, 1, 1.30, 2, 2.30, 3, 4, 6 and 8-h after administration.
Time frame: From baseline to 8 hours after administration
Change in Maddox Wing score (MW)
Maddox wing is a device for the measurement of diopters of horizontal heterophoria. From 22 (exophoria) to 15 (esophoria). Higher scores mean worse outcome.Obtained baseline and 1.30, 4 and 6-h after administration.
Time frame: From baseline to 6 hours after administration
Beverage identification
Beverage identification questionnaire.There is an option to select each treatment condition. Only measured at 8h after administration
Time frame: 8 hours after administration
Change in tracking test performance
Test will be performed using a computer program. Total time outside the road and number of errors will be measured. Obtained baseline and 1.30, 4 and 6-h after administration.
Time frame: From baseline to 6 hours after administration
This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Fundació Institut Germans Trias i Pujol